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  • 1
    Online Resource
    Online Resource
    Springer Science and Business Media LLC ; 2017
    In:  International Journal of Clinical Pharmacy Vol. 39, No. 5 ( 2017-10), p. 980-984
    In: International Journal of Clinical Pharmacy, Springer Science and Business Media LLC, Vol. 39, No. 5 ( 2017-10), p. 980-984
    Type of Medium: Online Resource
    ISSN: 2210-7703 , 2210-7711
    Language: English
    Publisher: Springer Science and Business Media LLC
    Publication Date: 2017
    detail.hit.zdb_id: 2601204-2
    SSG: 15,3
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  • 2
    In: Journal of Sensory Studies, Wiley, Vol. 36, No. 1 ( 2021-02)
    Abstract: About half of the population aged over 60 years mention they have an olfactory dysfunction. However, the diagnosis is challenging since the identification of odors is personal and cultural, conditioning the selection of effective olfactory tests. This study aimed to identify typical odors recognized by the Portuguese population in order to develop and characterize a smell test kit adapted to this specific population to be used to diagnose olfactory dysfunctions. For this, a national cross‐sectional survey with 348 healthy participants, allowed the identification of 22 characteristic odors for Portuguese population. The orange odor was chosen by 56% of the individuals that answered the survey and this fragrance was selected for pre‐formulation studies. Then, polyethylene glycol (PEG)‐based formulations were developed and characterized. It was observed that the type and amount of PEG and fragrances influenced the rheology, morphology, texture and crystalline structures of the formulations. Based on the results obtained, structure characterization and sensorial analysis responses, compounding and processing, a formulation was selected. Then, the kit was assembled with 22 fragrance PEG‐based formulations and one odorless (control). Practical application This study aimed to identify 22 odors among different categories recognizable by the Portuguese population in order to develop a suitable smell test kit to diagnose olfactory dysfunctions of this specific population. This Portuguese smell test, for containing formulations with rheological and sensory characteristics adapted to the Portuguese population, allows the physician to use it as a method of diagnosis in patients with suspected impaired olfactory perception, such as anosmia total or partial. Nowadays, this kit is being used in otorhinolaryngology medical consultation of the hospital involved in the study to diagnose olfactory disorders.
    Type of Medium: Online Resource
    ISSN: 0887-8250 , 1745-459X
    URL: Issue
    Language: English
    Publisher: Wiley
    Publication Date: 2021
    detail.hit.zdb_id: 2179786-9
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  • 3
    In: Frontiers in Medicine, Frontiers Media SA, Vol. 7 ( 2020-11-23)
    Abstract: Non-Biological Complex Drugs (NBCDs) are complex non-biological drugs comprised of large high molecular weight molecules and, often, nanoparticular structures (including liposomes and block-copolymer micelles). In the case of NBCDs, the entire complex is the active pharmaceutical ingredient and its properties cannot be fully characterized by physicochemical analysis. Moreover, the manufacturing process is fundamental in creating the correct originator product. The same is true for generic versions of the product. A recent appraisal of approval procedures for NBCDs “follow-on products” approved in Europe shows a diversity of regulatory pathways. In fact, three different abridged application procedures, under European legislation, were used: the generic application procedure of Article 10(1), the hybrid application procedure of Article 10(3), and the biosimilar application procedure of Article 10(4). Three informed consent applications via Article 10(c) from innovator companies of glatiramer acetate and sevelamer carbonate were submitted shortly after the approval of the first follow-on products. Furthermore, a number of “well-established use” applications [via Article 10(a)] were approved for iron sucrose and iron dextran complexes. In order to protect patients from the increased risks of NBCD products and NBCD follow-on products, two complementary approaches should be considered: (i) improving the regulatory procedures and their guidance documents within the pre-registration phase, and (ii) not considering interchangeability whenever clinical data is not available. With regards to the latter, the need for adequate safety and efficacy data might also include risk management programmes within post-approval pharmacovigilance actions. This, however, would depend on a risk appraisal that must be considered for individual medicinal products, based on the nature of the submitted relevant set of safety/efficacy data.
    Type of Medium: Online Resource
    ISSN: 2296-858X
    Language: Unknown
    Publisher: Frontiers Media SA
    Publication Date: 2020
    detail.hit.zdb_id: 2775999-4
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  • 4
    In: International Journal of Technology Assessment in Health Care, Cambridge University Press (CUP), Vol. 33, No. S1 ( 2017), p. 92-93
    Abstract: Anemia is a major problem, frequently resulting from iron deficiency (1). Guidelines recommend the administration of intravenous (IV) iron, leaving blood transfusions for critical patients due to the potential impact in length of stay (LOS) and mortality (2,3). We aimed to characterize IV iron sucrose utilization and health resource utilization in anemic patients. METHODS: This is a retrospective ongoing cohort study. Patient records from a general Portuguese Hospital with an administration of iron sucrose in 2014–2015 were reviewed. Adult anemic patients with at least one hemoglobin (Hb) evaluation before and after the administration of IV iron were included. Endpoints assessed were: Hb level (baseline, 4 and 8 weeks after), anemia correction rate at weeks 4 and 8, blood transfusions, length of stay (LOS), rate of readmissions ( 〈 30 days) and inpatient mortality. Statistical analysis included non-parametric and chi-square tests to assess differences between groups and a logistic regression model, using a 5 percent significance level. RESULTS: Data was collected for 401 patients (63.1 percent female; mean age Standard Deviation, SD: 62.6 (21.7) years) and 431 IV iron sucrose administration episodes. Mean cumulative iron dose was 679.5 mg. Baseline Hb level was 84.5 g/l and increased to 94.3 g/l (week 4) and to 103.0 g/l (week 8). Blood transfusions were performed in 53.8 percent of the episodes. Overall 157 (36.4 percent) episodes had a 〉 20 g/l increase in Hb level. Blood transfusions were associated with a higher proportion of Hb level increase 〉 20 g/l (44.0 percent versus 27.9 percent, p 〈 .001). The overall mean LOS was 15.3 days, although episodes with transfusions had a significantly longer duration (17.5 days versus 12.7 days; p 〈 .001). Overall readmission rate was 25.8 percent, with a higher proportion in episodes with blood transfusions (29.3 percent versus 21.6 percent). A total of 36 patients (9.0 percent) died at the hospital before discharge. Transfusions performed during or after IV iron administration increased 3.1 times the risk of in-hospital death (95 percent Confidence Interval, CI: 1.3-7.0; p = .008), after adjusting for age and sex. CONCLUSIONS: We observed a high rate of blood transfusions in this cohort treated with intravenous iron sucrose for anemia. Transfusions were associated with substantial burden of resource consumption and in-hospital mortality.
    Type of Medium: Online Resource
    ISSN: 0266-4623 , 1471-6348
    Language: English
    Publisher: Cambridge University Press (CUP)
    Publication Date: 2017
    detail.hit.zdb_id: 2020486-3
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